OTC Overactive Bladder Treatment Approved

Oxytrol approved by FDA for women to treat bladder problem

(RxWiki News) Oxytrol for Women, a patch that is applied to the skin to treat overactive bladder, was approved by the Food and Drug Administration as an over-the-counter treatment.

The patch is the first over-the-counter medicine for overactive bladder in adult women over the age of 18.

The treatment for women contains the ingredient oxybutynin, which helps relax bladder muscles.

"Talk to a pharmacist about Oxytrol for Women."

Oxytrol for Women is the first medicine in the class of medications called anticholinergics to be made available as an over-the-counter treatment.

Oxytrol is available for men with the bladder control problem by prescription only.

Over nine studies involving more than 5,000 participants established Oxytrol for Women's safety and effectiveness for over-the-counter use.

Based on the results of these studies, consumers can understand the labeling information on the medication and use the medicine appropriately.

“Studies demonstrate that over-the-counter Oxytrol for Women is a safe and effective treatment for overactive bladder,” said Shaw Chen, MD, PhD, deputy director of the Office of Drug Evaluation IV in the FDA’s Center for Drug Evaluation and Research, in a press release.

“Women should make sure to follow the Drug Facts label and consult their doctor if their condition does not improve.”

A leaflet with tips to help deal with overactive bladder symptoms, which include leaking urine, feeling the sudden urge to urinate and urinating often, will be provided with the medicine.

Side effects of the medicine include mild irritation on the skin where the patch was applied, constipation and dry mouth. The medicine is marketed by Merck.

Review Date: 
January 26, 2013